HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study

2013 ◽  
Author(s):  
L Incrocci
Keyword(s):  
Prostate Cancer ◽  
Phase Iii ◽  
Multicentre Phase ◽  
Phase Iii Study ◽  
Hypofractionated Irradiation

scholarly journals Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study

2018 ◽  
Vol 109 (6) ◽  
pp. 1920-1929 ◽  
Author(s):  
Seiichiro Ozono ◽  
Taiji Tsukamoto ◽  
Seiji Naito ◽  
Shigeo Horie ◽  
Yasuo Ohashi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Dosing Regimen ◽  
Phase Iii Study ◽  
Japanese Subjects

Randomised, Multicentre Phase III Study of Saquinavir plus Zidovudine plus Zalcitabine in Previously Untreated or Minimally Pretreated HIV-Infected Patients

2000 ◽  
Vol 20 (5) ◽  
pp. 295-307 ◽  
Author(s):  
Hans-J??rgen Stellbrink ◽  
David A. Hawkins ◽  
Nathan Clumeck ◽  
David A. Cooper ◽  
Robert Myers ◽  
...  
Keyword(s):  
Phase Iii ◽  
Multicentre Phase ◽  
Phase Iii Study

The PACE trial: International randomised study of laparoscopic prostatectomy vs. stereotactic body radiotherapy (SBRT) and standard radiotherapy vs. SBRT for early stage organ-confined prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS153-TPS153 ◽  
Author(s):  
Kirsty Morrison ◽  
Alison Tree ◽  
Vincent Khoo ◽  
Nicholas John Van As ◽  
Keyword(s):  
Prostate Cancer ◽  
Stereotactic Body Radiotherapy ◽  
Treatment Time ◽  
Early Stage ◽  
Treatment Options ◽  
Therapeutic Benefit ◽  
Phase Iii ◽  
Overall Treatment Time ◽  
Multicentre Phase ◽  
Randomised Study

TPS153 Background: The development of Stereotactic Body Radiotherapy (SBRT) has provided a further treatment option for early stage prostate cancer. In addition to the benefits of an overall treatment time reduction, profound hypofractionation could result in therapeutic gain given the radiobiology of prostate cancer. Evidence suggests SBRT to be safe and effective; however randomised data is lacking comparing outcomes with standard treatment options. Aim: To assess whether SBRT offers therapeutic benefit in comparison to prostatectomy or standard radiotherapy. Methods: The PACE trial is an international multicentre phase III trial, comprising two parallel randomisation processes. Within PACE A, potential surgical candidates are randomised between radical prostatectomy and SBRT (36.25 Gy in 5 fractions). In PACE B, randomisation is between standard radiotherapy (78Gy in 39 fractions or 62Gy in 20 fractions) and SBRT (36.35Gy in 5 fractions). SBRT can be delivered using Cyberknife or gantry based techniques. Patients with low or intermediate risk prostate cancer are eligible for the trial, and are treated without the use androgen deprivation therapy. Follow up is for a period of 10 years. The aim is to recruit 234 patients to PACE A (117 in each arm) and 858 patients to PACE B (429 patients in each arm). Primary Objectives: PACE A: To determine whether there is improved quality of life after SBRT compared with surgery at 2 years post treatment, using EPIC score to measure urinary incontinence and bowel bother. PACE B: to determine whether SBRT is non-inferior to surgery in terms of freedom from biochemical/clinical failure at 5 years from randomisation. Progress: PACE A has been slower to recruit than anticipated due to the difficulties of a surgery versus radiotherapy randomisation. However, it is expected to reach target accrual, having recruited 57 patients from 3 centres. In contrast, PACE B is recruiting exceptionally well, open in 40 centres, and as of October 2017 recruited 762 patients. Accrual target is expected to be reached by the end of 2017. Clinical trial information: NCT01584258.

Concurrent or layered treatment with radium-223 (Ra-223) and enzalutamide (Enza) or abiraterone plus prednisone/prednisolone (Abi/pred): A retrospective study of real-world clinical outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5026-5026
Author(s):  
Neal D. Shore ◽  
A. Oliver Sartor ◽  
Cora N. Sternberg ◽  
Fred Saad ◽  
Bertrand F. Tombal ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Outcomes ◽  
Real World ◽  
Descriptive Analysis ◽  
Randomized Study ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Kaplan Meier ◽  
Radium 223 ◽  
Phase Iii Study

5026 Background: In clinical practice, Ra-223 is often combined with Enza or Abi/pred. ERA 223 (NCT02043678) showed increased fracture risk with concurrent Ra-223+Abi/pred. We assessed real-world symptomatic skeletal events (SSEs) and overall survival (OS) of pts with mCRPC who received concurrent or layered Ra-223+Enza or Abi/pred. Methods: Patients with mCRPC treated with Ra-223 in US cancer clinics from 1/01/2013 to 6/30/2017 were identified from a Flatiron prostate cancer registry of electronic health records. Treatment initiation defined subgroups: concurrent (both started within 30 days) or layered (1 started ≥30 days after the other). Baseline (BL) was the first dose of Ra-223. Descriptive analysis was performed for BL characteristics, SSEs, and OS (Kaplan–Meier). Results: Of 625 pts treated with Ra-223, 48% received Ra-223+Enza or Abi/pred. Layered treatment was more common (73%) than concurrent (27%). BL characteristics and clinical outcomes were summarized [Table]. Conclusions: In a real-world setting, Ra-223+Enza or Abi/pred treatment was mainly layered. SSE rates with layered vs concurrent Ra-223+Abi/pred varied between subgroups; results must be treated cautiously given small pt numbers and a non-randomized study. The ongoing PEACE III trial is investigating concurrent Ra-223+Enza; a Phase III study (ESCALATE) exploring layered Ra-223+Enza is planned. [Table: see text]

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